Millennium Announces Promising Early Study Results With VELCADE(TM) (bortezomib) For Injection Combined With Doxil in Patients With Advanced Multiple Myeloma
Tuesday June 3, 9:01 am ET
-- Additional combination studies, long-term data also presented at annual ASCO meeting --
CHICAGO, June 3 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) today announced that preliminary phase I study results were presented examining the use of its novel oncology product, VELCADE, in combination with DOXIL® (doxorubicin liposome injection) for the treatment of patients with advanced stage multiple myeloma that have failed multiple prior treatments. Also presented was a combination study of VELCADE and melphalan in multiple myeloma, as well as further analyses from the phase II SUMMIT and CREST trials. The data from these studies were presented this week at the 39th American Society of Clinical Oncology (ASCO) meeting in Chicago.
In the VELCADE and DOXIL study, 23 patients with relapsed or refractory multiple myeloma were treated, including 13 with disease that previously did not benefit from, or progressed on, anthracycline therapy. Nineteen of the 20 evaluable patients experienced a response or a stabilization of their disease. Overall:
Twelve patients achieved complete (n=five), near complete (n=two) or partial (n=five) responses;
An additional three patients experienced minor responses and four patients experienced stable disease; and
One patient experienced progressive disease.
There were no apparent additive toxicities reported with the combination of VELCADE and DOXIL. The most commonly reported adverse events included fatigue, nausea, vomiting, constipation, diarrhea and peripheral neuropathy.
"We are encouraged by the responses seen in this preliminary combination study of VELCADE and DOXIL," said Dr. Robert Orlowski, lead study investigator, University of North Carolina, Chapel Hill. "With further study, we hope to be able to provide patients a new option in their fight against multiple myeloma."
Additional Combination Studies with VELCADE(TM) (bortezomib) for Injection VELCADE is also being investigated in combination with a number of other commonly used anti-myeloma agents. Preliminary results from a separate, ongoing phase I/II trial being conducted by James Berenson, M.D. at Cedars- Sinai Medical Center in Los Angeles, indicated that all 15 patients with relapsed and refractory multiple myeloma receiving VELCADE combined with melphalan experienced responses or had their disease stabilize, and the combination was generally well-tolerated. The most commonly reported adverse events were nausea, fatigue, diarrhea, fever, neutropenia and thrombocytopenia.
Also reported at the meeting were results of patients in the SUMMIT and CREST trials who received high-dose dexamethasone after they had not responded to, or relapsed after, treatment with VELCADE alone. Of the total 101 evaluable patients who had dexamethasone added to their VELCADE treatment regimen, 22 percent experienced responses who had previously not responded to treatment with VELCADE alone, with toxicity similar to VELCADE alone. Responses to combination therapy were seen in patients refractory to VELCADE and dexamethasone as single agents.
Further SUMMIT and CREST Analyses
Additional data from phase II SUMMIT and CREST trials of patients with multiple myeloma were evaluated to examine the long term safety and effectiveness of VELCADE in responders who continued treatment in an extension trial (029). VELCADE (with or without dexamethasone) was administered to patients with relapsed or refractory multiple myeloma for up to 24 cycles (approximately 18 months), including treatment received in both the original trial and 029, with a side effect profile similar to the first six months of treatment.
"We are very encouraged that, in this study, patients with advanced multiple myeloma tolerated treatment with VELCADE well beyond six months," said David Schenkein, M.D., vice president, clinical oncology development at Millennium. "We plan to further investigate the use of VELCADE in longer-term settings to better understand its role in the overall multiple myeloma treatment paradigm."
Other analyses from the major phase II SUMMIT trial presented at the
meeting included:
-- Data showing that complete and partial response rates were independent
of the number or type of prior treatments; and
-- Date relating to several genomic markers that may have predictive value
for response -- to be validated in future clinical trials with VELCADE.
About VELCADE
VELCADE, the first of a new class of medicines called proteasome inhibitors, is the first treatment in more than a decade to be approved for patients with multiple myeloma -- a cancer of the blood. Millennium received approval from the U.S. Food and Drug Administration on May 13, 2003 to market VELCADE for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. The effectiveness of VELCADE is based on response rates. There are no controlled trials demonstrating a clinical benefit such as an improvement in survival.
VELCADE has a generally predictable, manageable safety profile (with appropriate monitoring and, if necessary, dose modification). VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol.
In 228 patients who were treated with VELCADE(TM) (bortezomib) for Injection in two phase II studies of multiple myeloma, the most commonly reported adverse events were asthenic conditions (including fatigue, malaise and weakness) (65 percent), nausea (64 percent), diarrhea (51 percent), appetite decreased (including anorexia) (43 percent), constipation (43 percent), thrombocytopenia (43 percent), peripheral neuropathy (including peripheral sensory neuropathy and peripheral neuropathy aggravated) (37 percent), pyrexia (36 percent), vomiting (36 percent), and anemia (32 percent). Fourteen percent of patients experienced at least one episode of grade four toxicity, with the most common toxicity being thrombocytopenia (three percent) and neutropenia (three percent). A total of 113 (50 percent) of the 228 patients experienced serious adverse events (SAEs). The most commonly reported SAEs included pyrexia (seven percent), pneumonia (7 percent), diarrhea (6 percent), vomiting (5 percent), dehydration (5 percent) and nausea (4 percent).
About Multiple Myeloma
Multiple myeloma (also known as myeloma or plasma cell myeloma) is a cancer of the blood in which malignant plasma cells are overproduced in the bone marrow. Plasma cells are white blood cells that help produce antibodies called immunoglobulins that fight infection and disease. However, most patients with multiple myeloma have cells that produce a form of immunoglobulin called paraprotein (or M protein) that does not benefit the body. In addition, the malignant plasma cells replace normal plasma cells and other white blood cells important to the immune system. Multiple myeloma cells can also attach to other tissues of the body, such as bone, and produce tumors. The cause of the disease is unknown.
Multiple myeloma is the second most common cancer of the blood, representing approximately one percent of all cancers and two percent of all cancer deaths. It is estimated that approximately 45,000 Americans have multiple myeloma with about 15,000 new cases diagnosed each year. Only about 30 percent of multiple myeloma patients survive longer than five years with the disease. Although the disease is predominantly a cancer of the elderly (the average age at diagnosis is 70 years of age) recent statistics indicate both increased incidence and younger age of onset.
About Millennium
Millennium Pharmaceuticals, Inc., a leading biopharmaceutical company, co- promotes INTEGRILIN® (eptifibatide) Injection, a market-leading cardiovascular product, markets VELCADE(TM) (bortezomib) for Injection, a novel cancer product, and has a robust clinical development pipeline of product candidates. The Company's research, development and commercialization activities are focused in four disease areas: cardiovascular, oncology, inflammation and metabolic. By applying its knowledge of the human genome, its understanding of disease mechanisms, and its industrialized technology platform, Millennium is developing breakthrough personalized medicine products. Headquartered in Cambridge, Mass., Millennium also has facilities in South San Francisco, Calif. and Cambridge, UK
This press release contains "forward-looking statements," including statements about our growth and future operating results, discovery and development of products, potential acquisitions, strategic alliances and intellectual property. Various risks may cause the Company's actual results to differ materially, including: adverse results in our drug discovery and clinical development processes; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services based on our work; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the commercial success of INTEGRILIN® (eptifibatide) Injection and VELCADE(TM) (bortezomib) for Injection; and the requirement for substantial funding to conduct research and development and to expand commercialization activities. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
DOXIL® is a registered trademark of Ortho Biotech.
Editors' Note: This press release is also available under the Media section of the Company's website at: www.millennium.com.
Contacts:
Kelly Lindenboom (media) Gina Nugent (investor)
(617) 679-7405 (617) 551-3611
--------------------------------------------------------------------------------
Source: Millennium Pharmaceuticals, Inc. |
